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Geron Appoints Vice President, Pharmacovigilance and Drug Safety
MENLO PARK, Calif., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced the hiring of the first of several key leadership positions as it rebuilds the in-house development team to support its plans to initiate a Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes by mid-year 2019.
Israel Gutierrez, M.D., has joined the Company as Vice President, Pharmacovigilance and Drug Safety, as of January 16, 2019. Dr. Gutierrez will lead and direct the oversight of clinical drug safety risk management and compliance at Geron and will be responsible for product safety-related recommendations and decisions. Additionally, he will be responsible for ensuring compliance for all current and planned imetelstat clinical trials in accordance with domestic and international requirements for drug safety oversight and reporting from late-stage development through commercialization. As the senior pharmacovigilance expert, Dr. Gutierrez will lead and oversee pharmacovigilance signal detection and risk management activities and risk mitigation strategies, as well as represent medical safety at all meetings with regulatory authorities.
Dr. Gutierrez has more than 20 years of experience in clinical development and a deep knowledge of data collection/monitoring, signal detection, risk management and benefit-risk quantification and assessment, with expertise in both pre- and post-registration settings, including multiple product approvals. Most recently, he was the President of Innovation and Co-founder of Clindatum, LLC, a consulting firm focused on the clinical development of small molecules, biologics and devices. Prior to that, Dr. Gutierrez was Senior Director, Drug Safety and Pharmacovigilance at Pharmacyclics and a member of the hematology-oncology development team. Dr. Gutierrez has also been part of the oncology development teams at Exelixis, Inc., Genentech, a member of the Roche Group, and Celgene Corporation. Before a career in clinical development, he was a clinical research scientist at Loma Linda University in Loma Linda, California. Dr. Gutierrez has a B.S. in Biology from Cervantes College in Jalisco, Mexico and an M.D. from Universidad Autonoma de Guadalajara, Jalisco, Mexico.
In connection with the commencement of his employment with the Company, the Company granted Dr. Gutierrez a non-statutory stock option to purchase 400,000 shares of Geron common stock on January 16, 2019 at an exercise price of $1.09 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock option has a 10-year term and vests over four years, with 12.5% of the shares underlying the option vesting on the six-month anniversary of commencement of employment and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to Dr. Gutierrez’s continued employment with Geron. The option was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a stock option agreement covering the grant and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.
Geron is a clinical stage biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding that the Phase 3 clinical trial in lower risk myelodysplastic syndromes will begin by mid-year 2019 and other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, to enable patient screening and enrollment of the Phase 3 clinical trial in lower risk myelodysplastic syndromes to begin by mid-year 2019; (ii) whether imetelstat is safe and efficacious, and whether any past or future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; and (iii) whether the transition of the imetelstat program from Janssen Biotech, Inc. to the Company proceeds on a timely basis to enable the Phase 3 clinical trial in lower risk myelodysplastic syndromes to begin by mid-year 2019. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2018. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
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